The EU Medical Device Regulation

The EU Medical Device Regulation is the European framework a device answers to. This branch divides it by the part of the regulation a writer has to know, in the order the regulation came about, works and is now being revised. It leaves what the rules count as a device, the comparison with a medicine's framework and the US and Swiss routes to the other parts of device regulation and market access, the documents the regulation requires to the branches on clinical investigations, clinical evaluation and post-market surveillance, and the In Vitro Diagnostic Regulation and the other rules for particular kinds of device to the branch on devices with requirements of their own.

• What the EU Medical Device Regulation changed — the directives it replaced and the implant scandal that ended them, the move from directives to regulations, the changes to scope and classification, clinical evidence and the obligations of economic operators, coordination, fees and confidentiality, how its wording is interpreted, the effects expected, the documents it creates for writers, and where the legislation and guidance are published
• How the transition to the Medical Device Regulation unfolded — the legislative sequence from proposal to date of application, how ready notified bodies and manufacturers were as the date approached, why application was postponed, how the first year of application and the extension that followed went, and what the transition asked of writers
• Conformity assessment and the notified body — the route a device takes to its CE mark, what a notified body is, how one is designated and how a manufacturer chooses one, the technical documentation it assesses, the closer scrutiny and changed role of notified bodies under the regulation, and the scientific advice and the expert-panel advice on orphan devices a manufacturer can seek before submitting
• Transparency for medical devices under the EU Medical Device Regulation — why device approvals left little on the public record, what the regulation and its database were expected to make public, the unique device identifier and device nomenclature, the rebuilt database's timetable, the funding and independence of device investigations, whether and how their results are published, and what the change asked of writers
• Revising the EU device regulations — the notified-body bottleneck and compliance costs behind the December 2025 proposal, its legislative timeline and objectives, the broader evidence base, equivalence and well-established technology, the breakthrough and orphan pathways, digital documentation, lighter certification and post-market cycles, the changes for in vitro diagnostics, the notified bodies' response, and the definitions still to be settled